Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer
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Purpose
The purpose of this study is compare overall survival of the test arm (CPT-11/S-1 combination) to the control arm (CPT-11 alone) in the subjects with S-1 refractory advanced gastric cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: S-1 + irinotecan Drug: irinotecan |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Phase II/III Trial of Second Line Chemotherapy Comparing CPT-11 Monotherapy Versus S-1/CPT-11 Combination for S-1 Refractory Gastric Cancer |
- In phase II part, progressive disease rate will be measured for the safety. In phase III part, overall survival will be measured for the benefit of doublet. [ Time Frame: Phase II: 6 weeks from treatment, Phase III: 2 years OS from randomization ] [ Designated as safety issue: Yes ]
- Adverse events, response rates, progression free survival, time to treatment failure, change over rates to 3rd line [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 300 |
| Study Start Date: | March 2008 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
CPT-11+ S-1
|
Drug: S-1 + irinotecan
Irinotecan 150mg/m2 iv on day one and S-1 po days 1 to 14 every 3 weeks until PD
Other Names:
|
|
Active Comparator: B
CPT-11
|
Drug: irinotecan
Irinotecan 150mg/m2 iv on day one every two weeks until PD
Other Name: CPT-11
|
Detailed Description:
Standard chemotherapy for advanced gastric cancer (AGC) in the US is Cisplatin/5-FU (CF) or docetaxel/CF (DCF), is in Europe epirubicin/CF (ECF) or epirubicin/oxaliplatin/ capecitabine (EOX). Until 2006, there was no evidence of standard chemotherapy for AGC in Japan. In 2007, by the results of JCOG9912 trial (5-FU alone vs. CPT-11/CDDP vs S-1) and SPIRITS trial (S-1 alone vs. S-1/CDDP), S-1/CDDP is regarded as a new standard regimen in Japan. In 2008, by the results of TOP-002 trial (s-1 alone vs. S-1/CPT-11), S-1/CPT-11 could not show the superiority to S-1 alone. One of the other phase III trials, JACCRO GC-03 trial (S-1 alone vs. S-1/docetaxel, NCT00287768) is now ongoing. However, the position of CPT-11 in the treatment of AGC will be regarded as a second-line.
In Japan there is a controversy for the treatment of S-1 refractory gastric cancer. The controversy is continuing S-1 (like FOLFOX to FOLFIRI) or not as a second-line. After the successful adjuvant S-1 results (ACTS-GC trial), the same problem will occur in the patients who are recurrent from adjuvant S-1.
Then, we conducted a phase II/III trial of CPT-11 with or without S-1 in the treatment of first-line S-1 refractory AGC.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically proven inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) or relapse gastric adenocarcinoma
- Subjects must be able to take orally
- Subjects must be confirmed to be PD status by picture diagnosis after first-line chemotherapy using S-1 alone, S-1 + Cisplatinum or S-1 + taxane, except S-1 + CPT-11
- Within 4 weeks from the diagnosis of PD
- Total dosage of S-1 at the first-line is over 2,240mg/m2 in S-1 alone treatment, 1,680mg/m2 in the S-1 combination
- ECOG performance status ≤ 1
- Follow up Age 20 or over
- Life expectancy estimated more than 12 weeks
- Hgb ≥ 8 g/dL, WBC 4,000-12,000/mm3, ANC ≥ 2,000/mm3, platelets ≥ 100,000/mm3
- Creatinine ≤ upper normal limit (UNL)
- Total bilirubin ≤ 1.5 X UNL
- Written informed consent
Exclusion Criteria:
- S-1 + CPT-11 was employed as a first-line
- Any other cytotoxic agents therapy, immuno-therapy, radiation-therapy
- After S-1 adjuvant
- Suspended cases by adverse events by S-1 or S-1 combination
- Excessive amounts of ascites require drainage
- Known brain metastases
- History of hypersensitivity to fluoropyrimidines and CPT-11
- Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
- Active double cancer
- Gastrointestinal bleeding
- Any subject judged by the investigator to be unfit for any reason to participate in the study
Contacts and Locations
Show 86 Study Locations| Principal Investigator: | Masashi Fujii, M.D.,PhD | Surugadai Nihon University Hospital |
More Information
No publications provided
| Responsible Party: | Masashi Fujii/Associate Professor, Department of Digestive Surgery, Surugadai Nihon University Hospital |
| ClinicalTrials.gov Identifier: | NCT00639327 History of Changes |
| Other Study ID Numbers: | JACCRO GC-05 |
| Study First Received: | March 5, 2008 |
| Last Updated: | June 27, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Japan Clinical Cancer Research Organization:
|
Stomach Neoplasms Second line chemotherapy Refractory to S-1 |
irinotecan S-1 and Irinotecan Combination Phase III study |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Irinotecan Antineoplastic Agents, Phytogenic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013